Air Filtech Completes Cleanroom Air Filtration Upgrade to EU GMP Annex 1 Standards for a Pharmaceutical Factory in Binh Duong
Air Filtech has recently completed a comprehensive cleanroom air filtration system upgrade for a pharmaceutical factory in Binh Duong Industrial Park, enabling the system to meet the EU GMP Annex 1 (2022 revision) requirements — mandatory standards for pharmaceutical manufacturing facilities supplying the European market.
Project Scope
The project included the replacement and upgrade of the air filtration system for four cleanroom areas classified as Grade A/B/C/D, covering a total area of more than 1,200 m².
Air Filtech implemented a comprehensive solution including:
- Camfil H14 HEPA filters for Grade A and Grade B areas, achieving a filtration efficiency of ≥99.995% at MPPS in accordance with EN 1822.
- Terminal Housing Green — an Air Filtech specialized product — installed throughout the ceiling area of the sterile compounding cleanroom.
- A tiered positive-pressure control system maintaining a differential pressure of ≥15 Pa between cleanroom grades.
- Optimized airflow direction and contamination control in accordance with EU GMP Annex 1 requirements.
Customer Feedback
Mr. Nguyen Van Minh — the factory’s Technical Director — shared:
“After Air Filtech completed the upgrade, we passed our first GMP inspection by the European regulatory authority without any observations requiring corrective action. This achievement was the result of thorough preparation with Air Filtech, from the design stage through to final acceptance.”
Testing and Handover
The entire project was handed over with a complete set of technical documentation to support GMP assessment:
- IQ/OQ (Installation Qualification / Operational Qualification) documentation.
- Results of HEPA filter leak and integrity testing using the DOP/PAO test method.
- A plan for periodic HEPA filter inspection every 12 months in accordance with EU GMP Annex 1 requirements.
Trusted Partner in Clean Air Filtration
Air Filtech is currently a cleanroom air filtration solutions provider for more than 30 factories across the pharmaceutical, food, and semiconductor industries in Vietnam.
→ Learn more about cleanroom solutions: airfiltech.vn/giai-phap/khi-sach-cleanroom
